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FDA Reverses Course, Will Review Moderna's mRNA Flu Vaccine mRNA-1010

Feb 26, 2026

The FDA agreed to review Moderna's mRNA-1010 seasonal flu vaccine after initially refusing to file the application, setting a decision date of August 5, 2026. If approved, it would be the first mRNA-based seasonal influenza vaccine on the market.

FDA Reverses Course, Agrees to Review Moderna's mRNA Flu Vaccine Application

Feb 17, 2026

The FDA agreed to review Moderna's mRNA-based flu vaccine after initially refusing, accepting a split regulatory approach with traditional approval for ages 50-64 and accelerated approval for 65 and older. Decision date set for August 5, 2026.